CurrentHealth NetPolicy CP PHAR481

Idecabtagene vicleucel (Abecma) — Coverage Criteria

Coverage and clinical criteria for idecabtagene vicleucel (Abecma) for treatment of multiple myeloma, including dosing, contraindications/boxed warnings, product availability, and coding implications. Applies to providers submitting authorizations and claims to the payer.

Policy Summary

PayerHealth Net

PolicyIdecabtagene vicleucel (Abecma) — Coverage Criteria

Policy CodePolicy CP PHAR481

Change TypeNo material change

Effective DateMar 26, 2021

Next Review Date

Key ActionSubmit prior authorization (HCPCS Q2055) with documentation of relapsed/refractory multiple myeloma, IMWG progressive disease evidence, planned single IV infusion and target dose (300-510 x 10^8 CAR+ T cells).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

single IVadministration format

300-510 x10^8target dose

510 x10^8maximum per dose

boxed warningssafety risks

single-dose frozenproduct

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Coverage Criteria

Initial therapy / Coverage criteria

Covered when ALL of the following are met (policy-level summary based on document content in this window):

Eligibility: Member has relapsed or refractory multiple myeloma with measurable disease or progressive disease as defined by IMWG criteriaIMWG criteria per Appendix D

Policy updated to explicitly allow progressive disease per IMWG; see full policy for Appendix D details

Prior therapy history: Member meets line-of-therapy requirements per current policy (verify number of prior systemic therapies and prior anti-BCMA therapy status in request)per policy

Policy history documents revisions to required prior therapies and added requirement that member has not previously received anti-BCMA therapy in 2Q 2022; confirm current requirement in authorization

CNS involvement exclusion: No known CNS involvement with multiple myeloma or history/presence of clinically relevant CNS pathology per KarMMa trial exclusionsper KarMMa protocol

KarMMa excluded patients with CNS involvement; policy aligned this exclusion in 2Q 2022 update

Administration and dosing: Planned administration as a single IV infusion of autologous BCMA-directed CAR T cells with target dose 300-510 x 10^8 CAR-positive T cells and a maximum of 510 x 10^8 CAR-positive T cells per therapeutic dose300-510 x 10^8 (max 510 x 10^8)

Ensure coding uses HCPCS Q2055 and documentation includes proposed dose and single IV infusion plan

This policy excludes members with known CNS involvement of multiple myeloma or a history/presence of clinically relevant CNS pathology consistent with exclusions used in the pivotal KarMMa trial. The KarMMa study specifically excluded patients with CNS involvement, and the policy aligns its active CNS disease exclusion to that trial language.

Requests should be evaluated for documented CNS disease (history, imaging, or clinical notes) before authorization; presence of CNS involvement per the KarMMa-defined criteria is an exclusion to coverage for idecabtagene vicleucel.

Policy history documents revisions to prior-therapy requirements and anti-BCMA exposure. In 2Q 2021 the criteria were revised (previously 3 therapies) to reflect FDA labeling changes, and in 2Q 2022 the policy added a requirement that the member has not previously received anti-BCMA targeted therapy. All requests continue to require medical director review per policy.

Because prior-therapy requirements have changed over time (including adjustments to the number of prior lines and restrictions on prior anti-BCMA agents), verify and document the member's systemic therapy history and prior exposure to BCMA-targeted treatments in the authorization request.

Administration and Product Details

Administration / Product

Administration and product details:

Administration: Single IV infusion of autologous BCMA-directed CAR T cellssingle-dose

Product is supplied as a single-dose frozen suspension labeled for the specific recipient and administered as a single IV infusion where acute toxicities can be monitored

Product form: Single-dose frozen autologous T-cell suspension labeled for the specific recipientsingle-dose

Product availability described as a single-dose frozen suspension

Dosing and coding: Target CAR-positive T-cell dose 300-510 x 10^8 with maximum 510 x 10^8 CAR-positive T cells per therapeutic dose; bill using HCPCS Q2055 as described300-510 x 10^8 (max 510 x 10^8)

HCPCS Q2055 description specifies up to 510 million (510 x 10^8) CAR-positive T cells including leukapheresis and dose preparation per therapeutic dose

Coding and Dose Limits

Covered HCPCS CodesHCPCSCovered

Q2055

Idecabtagene vicleucel, up to 510 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures_per therapeutic dose

CAR-positive T-cell dose — target and maximum per dose

Target per therapeutic dose300 - 510 x 10^8 CAR-positive T cells (target dose range)

Maximum per therapeutic dose510 x 10^8 CAR-positive T cells (510 million)

Administration format linked to dosingSingle IV infusion (dose administered as a single therapeutic infusion)

idecabtagene vicleucel — quantity limits

Quantity limit (cells)Up to 510 million CAR-positive T cells (510 x 10^8) per therapeutic dose

HCPCS code referencedQ2055 — idecabtagene vicleucel, up to 510 million autologous BCMA-directed CAR-positive T cells (per therapeutic dose)

IncludesLeukapheresis and dose preparation procedures included in the HCPCS Q2055 description

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Q2055 (idecabtagene vicleucel). All requests reviewed under this policy require medical director review and authorization prior to administration.

HCPCS Q2055 — Idecabtagene vicleucel, up to 510 million autologous BCMA‑directed CAR‑positive T cells (including leukapheresis and dose preparation) (see coding guidance)
Medical director review required for all prior authorization requests

Denial Risk

Safety-related Denial Risk

Requests may be denied or site restrictions applied when safety concerns exist. This therapy has boxed warnings for cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged cytopenia, and secondary hematologic malignancies. Consideration of Actemra (tocilizumab) authorization may be relevant when CRS management is requested.

Boxed warnings: cytokine release syndrome, neurologic toxicities, HLH/MAS, prolonged cytopenia, secondary hematologic malignancies
Providers should document plans for CRS/neuro toxicity management (e.g., availability of tocilizumab) as applicable

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation with the authorization request to support medical necessity and eligibility.

Diagnosis of relapsed or refractory multiple myeloma consistent with policy definitions
Documentation of measurable disease and evidence of progressive disease per IMWG criteria (e.g., serum/urine M‑component changes, FLC changes, new lesions, bone marrow/plasma cell percentage, circulating plasma cells)
Prior therapy history: lines of therapy received and documentation that member has not previously received anti‑BCMA targeted therapy when applicable
Planned dose (e.g., target dose 300–510 x 10^8; up to 510 x 10^8 CAR‑positive T cells) and administration setting
Supporting records: relevant labs, imaging, pathology, prior treatment records, and any documentation of CNS disease exclusion or clinically relevant CNS pathology

Documentation Required

Line-of-Therapy Verification

Verify prior lines of therapy and appropriateness of current line‑of‑therapy for this indication. Policy revisions updated line‑of‑therapy criteria (e.g., earlier use after two or more lines) and added the requirement that members have not previously received anti‑BCMA targeted therapy.

Confirm number and types of prior systemic therapies (lines of therapy) — include dates and agents
Confirm member meets current policy threshold for line of therapy (per latest effective policy language and clinical updates)
Document any exclusionary prior treatments (e.g., prior anti‑BCMA therapy) to avoid inappropriate authorization

Site of Care and Administration Setting

Note

Administer in hospital outpatient or infusion center with acute toxicity monitoring

Administer idecabtagene vicleucel in a hospital outpatient or infusion center setting able to monitor for and manage acute toxicities; verify facility capabilities as part of the authorization.

Ensure the administration site can monitor for CRS, neurologic events, and other acute adverse events per boxed warnings.
Confirm planned single IV infusion will occur at a facility equipped for immediate management of severe toxicities.

Definitions and Trial Criteria

IMWG progressive disease criteria — progression thresholds

M-protein increase threshold (urine)≥25% increase from nadir in urine M-component with absolute increase ≥ 200 mg/24 h

M-protein increase threshold (serum)≥25% increase from nadir in serum M-component with absolute increase ≥ 0.5 g/dL

New lesions or lesion growthAppearance of new lesion(s), or ≥50% increase from nadir in SPD of >1 lesion, or ≥50% increase in longest diameter of a previous lesion >1 cm in short axis

FLC levels (when serum/urine not measurable)≥25% increase from nadir in involved–uninvolved free light chain difference with absolute increase >10 mg/dL

Bone marrow plasma cells (when other measures not measurable)≥25% increase from nadir in bone marrow plasma cell percentage with absolute increase ≥10%

Circulating plasma cells250% increase in circulating plasma cells (minimum 200 cells/µL) if sole measure of disease progression

KarMMa trial exclusion — CNS involvement alignment

KarMMa trial CNS exclusionPatients with CNS involvement of multiple myeloma were excluded from the pivotal KarMMa trial

Policy alignmentPolicy excludes known CNS involvement with myeloma or history/presence of clinically relevant CNS pathology per KarMMa protocol

Implication for authorizationRequests should document absence of clinically relevant CNS pathology to meet exclusion criteria

Step Therapy / Prior Treatment Verification

Step	Requirement	Documentation to confirm
1	Confirm prior systemic therapy history meets current policy line-of-therapy requirements (verify number and type of prior lines; policy history revised prior therapy requirements over time and may allow use after two or more prior lines depending on most recent criteria)	Clinical summary of prior systemic therapies including regimen names, number of completed lines, dates of therapy, and any intolerances or documented treatment failures
2	Verify member has not previously received anti-BCMA targeted therapy when applicable per policy revision (2Q 2022 update added this requirement)	Medication administration records, prior authorization/claim history, or provider statement confirming no prior anti-BCMA therapy
3	Confirm diagnosis and disease status meet coverage criteria (relapsed or refractory multiple myeloma with measurable disease or progressive disease per IMWG criteria)	Diagnostic records, IMWG progression documentation (laboratory/imaging/pathology) or treating physician note describing measurable or progressive disease per IMWG
4	Ensure planned administration and dosing align with policy (single IV infusion; target dose 300–510 x 10^8 CAR+ T cells; maximum 510 x 10^8 per therapeutic dose; coding must reflect HCPCS Q2055)	Treatment plan showing planned single IV infusion, target dose and cell count, and billing code Q2055 with stated CAR+ T-cell quantity

Background

Idecabtagene vicleucel (ide-cel, Abecma) is an autologous BCMA-directed CAR T-cell therapy supplied as a single-dose frozen autologous T‑cell suspension labeled for the intended recipient and administered as a single IV infusion.

The approved indication is for relapsed or refractory multiple myeloma per trial and labeling language; dosing is planned as a target of 300–510 x 10^8 CAR-positive T cells with a maximum permitted dose of 510 x 10^8 (510 million) CAR-positive T cells per therapeutic dose.

Serious safety risks are identified in boxed warnings and must be considered at the time of treatment: cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenia, and secondary hematologic malignancies. Administration must occur where acute toxicities can be monitored and managed.